Fiber Formula Study Among Radiation Oncology Patients

September 23, 2011 updated by: Lisa Epp, Mayo Clinic

Pilot Study: "Does Using a Fiber Containing Enteral Tube Feeding Formula Increase Constipation and the Use of Stool Softeners in Patients Undergoing Radiation Therapy and Have a Percutaneous Endoscopic Gastrostomy (PEG) Placed?"

During radiation treatment for head and neck cancer a large percentage of patients at Mayo Clinic Rochester develop the need for tube feeding to meet nutrition and hydration needs. These patients are usually taking pain medication along with a stool softener or laxative. Currently, when these patients get a feeding tube it is our standard practice to choose a fiber-free enteral tube feeding formula as to not worsen their constipation. Currently, there are no guidelines as to which patients are good candidates for fiber containing enteral tube feeding formulas. The investigators hope this study will help determine if fiber containing enteral tube feeding formulas can be used for patients undergoing radiation for head and neck cancer without increasing rates of constipation or increasing use of stool softeners/laxatives.

Hypothesis: Participants enrolled in the study will not have increased rates of constipation on fiber-containing enteral tube feeding formula compared to historical standards on fiber-free formula.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

19

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

These participants have head and neck cancer, are undergoing radiaiton therapy and will have a percutaneous endoscopic gastrostomy (PEG) placed.

Description

Inclusion Criteria:

  • Cancer of: 1) lip/oral cavity 2) pharynx 3) larynx 4) nasal cavity/paranasal sinus 5) salivary gland 6) Thyroid according to AJCC cancer staging manual 6th edition 2002
  • Current radiation therapy or starting radiation therapy in the next 2 weeks
  • Patient must have a gastrostomy tube

Exclusion Criteria:

  • Jejunostomy tube
  • Diagnosis of Irritable Bowel Syndrome (abdominal pain and diarrhea or constipation lasting at least three months in one year)
  • Short bowel (A patient is generally considered to have short bowel syndrome when less than 100 to 150 centimeters of functioning small bowel remains)
  • Body max index (BMI) <18.5kg/m2
  • Gastroparesis (when the stomach retains food for longer than normal periods). This must be diagnosed with a gastric emptying study.
  • Use of Metoclopramide
  • Receiving 5-FU chemotherapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Fiber formula
This group will receive tube feeding formula that contains fiber.
Dietary supplement: Fiber containing tube feeding formula
This group will be prescribed adequate calories, protein and fluid using a formula that contains fiber.
Other Names:
  • There is no brand name we are using. We will use the formula that best meets the patient calorie, protein and fluid needs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Whether each patient gets constipated.
Time Frame: Weekly for 2 weeks
Weekly for 2 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Whether the amount of stool softeners/laxatives increases in comparison to the original recommended regimen, for each individual patient.
Time Frame: Weekly for 2 weeks
Weekly for 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Lisa M Epp, BS, Mayo Clinic
  • Study Director: Yolanda I Garces, MD, Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

April 24, 2009

First Submitted That Met QC Criteria

April 24, 2009

First Posted (Estimate)

April 27, 2009

Study Record Updates

Last Update Posted (Estimate)

September 26, 2011

Last Update Submitted That Met QC Criteria

September 23, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-005304

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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